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Clearmind Medicine Partners with Dr. Gabor Maté to Discuss Alcohol Use Disorder and Trauma in a Special Virtual Event on February 3

January 30th, 2022 1:45 am

A renowned speaker, and bestselling author, Dr. Gabor Maté is highly sought after for his expertise on a range of topics including addiction, stress and childhood development

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Sorrento Announces Its Oral SARS-CoV-2 Main Protease (Mpro) Inhibitor, STI-1558, Strongly Neutralizes Omicron

January 30th, 2022 1:45 am

SAN DIEGO, Jan. 28, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced its late-stage preclinical Mpro inhibitor, STI-1558, effectively inhibits Omicron virus entry and replication in cell-based assays.

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Humacyte Announces Preclinical Results of Small-Diameter Human Acellular Vessel™ (HAV™) in Coronary Artery Bypass Grafting

January 30th, 2022 1:45 am

-- HAV remained patent and host-cell remodeling was observed in non-human primate model ---- Preclinical study represents milestone in the development of small-diameter HAVs for use in cardiac bypass surgery --

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Catalyst Pharmaceuticals Announces Issuance of Mandate by the U.S. Court of Appeals for the 11th Circuit Directing the District Court Judge in…

January 30th, 2022 1:45 am

CORAL GABLES, Fla., Jan. 28, 2022 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases, today reported that the U.S. Court of Appeals for the 11th Circuit has issued a mandate directing the District Court that heard Catalyst's claim against the FDA to enter summary judgment in favor of Catalyst in its lawsuit against the FDA, thereby vacating the FDA's approval of Ruzurgi® (Jacobus Pharmaceutical Company's amifampridine product).

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ObsEva Announces Corporate Updates

January 30th, 2022 1:45 am

Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange

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Mainz Biomed Announces the Closing of its $25.8 Million Public Follow-on Offering of Common Stock and Full Exercise of the Underwriters’ Option to…

January 30th, 2022 1:45 am

Proceeds Allocated to Development of Recently Acquired mRNA Biomarkers and Launch of Clinical Studies to Support ColoAlert’s FDA Submission Proceeds Allocated to Development of Recently Acquired mRNA Biomarkers and Launch of Clinical Studies to Support ColoAlert’s FDA Submission

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Soleno Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

January 30th, 2022 1:45 am

REDWOOD CITY, Calif., Jan. 28, 2022 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced, as required by Nasdaq Stock Market rules, the grant of inducement awards to new employees.

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PAOG Publishes 2022 Strategic Update

January 30th, 2022 1:45 am

Sandusky, OH, Jan. 28, 2022 (GLOBE NEWSWIRE) -- PAO Group, Inc. (OTC Pink: PAOG) today released a 2022 strategic update on the company’s CBD pharmaceutical and nutraceutical development strategy. The update is included in its entirety below:

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Avicanna Announces Closing of Non-Brokered Private Placement of Convertible Debenture Units

January 30th, 2022 1:45 am

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES. ANY FAILURE TO COMPLY WITH THIS RESTRICTION MAY CONSTITUTE A VIOLATION OF UNITED STATES SECURITIES LAWS

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Mountain Valley MD Holdings Announces Restricted Share Unit Plan, RSU Grant and Stock Option Grant

January 30th, 2022 1:45 am

TORONTO, Jan. 28, 2022 (GLOBE NEWSWIRE) -- Mountain Valley MD Holdings Inc. (the “Company” or “MVMD”) (CSE: MVMD) (OTCQX: MVMDF) (FRA: 20MP) announces the adoption of a restricted share unit plan (the "RSU Plan"), a grant of restricted share units pursuant to the RSU Plan (each, an "RSU") and the grant of stock options pursuant to its existing stock option plan (the “Stock Option Plan”).

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Twelve Rutgers Professors Named Fellows of the American Association for the Advancement of Science – Rutgers Today

January 30th, 2022 1:45 am

MaxHggblom Distinguished Professor and ChairDepartment of Biochemistry and MicrobiologySchool of Environmental and Biological SciencesRutgers-New BrunswickHonored for distinguished contributions to understanding both the fundamental and application components of microbialbiotransformationsof pollutants, especially chlorinated aromaticcompoundsand metalloids.

MaxHggblomis a renowned research scientist and educator with a large body of microbial ecology and environmental biotechnology research that has expanded our understanding of how the biodegradation of environmental pollutants, such as dioxins and PCBs,impact our planet.

His research interests revolve around thebioexploration, cultivation and characterization of novel microbes.His research on bacteria has provided a foundation for applications that address the pollution problems facing impacted industrialized and urbanized environments.

Hggblomslab is also actively studying microorganisms that degrade pharmaceutical and personal care products in aquatic environments.

Over the past decadesthediverse chemicalsin pharmaceutical and personal care productshave emerged as a major group of environmental contaminants in numerous watersheds around the world; therefore, it is important to understand how microbes can degrade them.There is much to explore and learn,Hggblomadded.

Hggblomswork also touches climate change, particularly the roles and responses of microbes in rapidly changing environments, such as the Arctic.In his lab at Rutgers, students have the unique opportunity to exploreareas of research such asthe biodegradation and detoxification of anthropogenic pollutant chemicals, including certainpesticides;respiration of rare metalloids; or life in the frozen tundra soils.

For several years,my lab has worked on studying the microbial ecology of Arctic tundra soils to understand how the changing conditions impact microbial activity and turnover of soil organic matter, and consequently enhanced greenhouse gas flux,Hggblomsaid. This is an important area of research as the threat of microbial contribution to positive feedback of greenhouse gas flux is substantial.

His lab recently received funding from the National Science Foundation to studyhowdiverse microbial communitiesare established insoils.Hggblomwill work with an international research team of scientists from the U.S., China, South Africa and Finland to study soils from the three differentregionsacross Arctic, Tibetan Plateau and Antarctic habitats to expand our understanding of how soil ecosystems respond in critical polar regions.

Emily EversonLayden

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FDA Grants Regenerative Medicine Advanced Therapy, Fast Track Designations to Novel CAR T-Cell Therapy for Relapsed, Refractory B-cell Non-Hodgkin…

January 17th, 2022 1:49 am

C-CAR039 showed positive efficacy and safety data in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

Officials with the FDA have granted both Regenerative Medicine Advanced Therapy (RMAT) Designation and Fast Track Designation to C-CAR039, a novel autologous bi-specific chimeric antigen receptor (CAR) T-cell therapy, for the treatment of patients with relapsed or refractory (r/r) diffuse large B cell lymphoma (DLBCL).

C-CAR039 targets both the CD19 and CD20 antigens, and early results from an investigator-led trial demonstrate positive efficacy and safety data in patients with r/r B-cell non-Hodgkin lymphoma. As of April 20, 2021, 34 patients received the therapy, 28 of whom were eligible for safety analyses and 27 of whom were evaluable for efficacy analyses. Patients median age was 55.5 years and 75% had cancer of Ann Arbor stage 3/4. Participants had a median of 3 prior lines of therapy and bridging therapy had been given to 17.9% of patients.

According to a press release, the best overall response rate was 92.6%, with a complete response rate of 85.2%. Patients had a median time to response of 1 month and at a median follow-up of 7 months, 74.1% of patients were still in complete remission. Furthermore, the 6-month estimated progression-free survival rate was 83.2%.

This is great news for CBMG that the FDA has granted C-CAR039 both RMAT and fast track designations based on its potential to increase objective and complete response rate in r/r DLBCL, said Tony Liu, chairman and CEO of Cellular Biomedicine Group, in the press release. The clinical data based on our clinical trials in China continue to support the hypothesis that C-CAR039 is the best-in-class CAR T asset for patients in this indication.

Cytokine release syndrome (CRS) was reported in 96% of patients, 92% of which was grade 1/2. Only 1 patient had grade 3 CRS. Immune effector cell-associated neurotoxicity syndrome occurred at grade 1 in 2 patients and no grade 2 or higher neurologic events were reported, according to the press release. The researchers will continue to evaluate patients with longer follow-up.

Separately, the FDA Office of Orphan Products Development granted an Orphan Drug Designation to C-CAR039 for the treatment of follicular lymphoma in June 2021. The Investigational New Drug application was cleared by the FDA on December 10, 2021.

We are working toward initiating 1b/2 trials for C-CAR039 in the US soon, Liu said in the press release. And we will work closely with the FDA to seek the best path forward to deliver the drug to patients in the US and EU.

REFERENCE

CBMG Receives FDA Regenerative Medicine Advanced Therapy and Fast Track Designations. News release. CBMG; January 12, 2022. Accessed January 13, 2022. https://www.cellbiomedgroup.com/newsroom/fda-rmat?lang=en

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Rising Focus on Exploring Potential of Stem Cells as Therapeutic Tools in Drug Targeting and Regenerative Medicine to Fuel Revenue Growth of Stem…

January 17th, 2022 1:49 am

NEW YORK, Jan. 10, 2022 /PRNewswire/ --Reports and Data has published its latest report titled "Stem Cells Market By Product (Adult Stem Cells, Human Embryonic Stem Cells, IPS Cells, and Very Small Embryonic-Like Stem Cells), By Technology (Cell Acquisition, Cell Production, Cryopreservation, and Expansion & Sub-Culture), By Therapies (Allogeneic Stem Cell Therapy and Autologous Stem Cell Therapy), and By Application (Regenerative Medicine and Drug Discovery & Discovery), and By Region Forecast To 2028."

According to the latest report by Reports and Data, the global stem cells market size was USD 10.13 billion in 2020 and is expected to reach USD 19.31 Billion in 2028 and register a revenue CAGR of 8.4% during the forecast period, 2021-2028.

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Drivers, Restraints, & Opportunities

Stem cells are cells that have the potential to differentiate into different types of cells in the body. Stem cells have the ability of self-renewal and differential into specialized adult cell types. Stems cells are being explored for their potential in tissue regeneration and repair and in treatment of chronic diseases. Increasing number of clinical trials are underway to assess and establish safety and efficacy of stem cell therapy for various diseases and disorders. Rapid advancement in stem cell research, rising investment to accelerate stem cell therapy development, and increasing use of stem cells as therapeutic tools for treatment of neurological diseases and malignancies are some key factors expected to drive market revenue growth over the forecast period. in addition, growing incidence of type 1 diabetes, spinal cord injuries, Parkinson's diseases, and Alzheimer's disease, among others have further boosted adoption of stem cell therapies and is expected to fuel revenue growth of the market going ahead.

Stem cells are basic cells in the body from which cells with specialized functions are generated such as heart muscle cells, brain cells, bone cells, or blood cells. Maturation of stem cells into specialized cells have enabled researchers and doctors better understand the pathophysiology of diseases and conditions. Stem cells have great potential to be grown to become new tissues for transplant and in regenerative medicine. Stem cells that are programmed to differentiate into tissue-specific cells are widely being used to test new drugs that target specific diseases, such as nerve cells can be generated to test safety and efficacy of drugs that are being developed for nerve disorders and diseases. Stem cells are of two major types: pluripotent cells that can differentiate into any cells in the adult body and multipotent cells that are restricted to differentiate into limited population of cells. Increasing clinical research is being carried out to advance stem cell therapy to improve cardiac function and to treat muscular dystrophy and heart failure. Recent progress in preclinical and clinical research have expanded application scope of stem cell therapy into treating diseases for which currently available therapies have failed to be effective. This is expected to continue to drive revenue growth of the market going ahead.

However, immunity-related concerns associated with stem cell therapies, increasing incidence of abnormalities in adult stem cells, and rising number of ethical issues associated with stem cell research such as risk of harm during isolation of stem cells, therapeutic misconception, and concerns surrounding safety and efficacy of stem cell therapies are some key factors expected to restrain market growth to a certain extent over the forecast period.

To identify the key trends in the industry, research study at https://www.reportsanddata.com/report-detail/stem-cells-market

COVID-19 Impact Analysis

Rising use of Human Embryonic Stem Cells in Regenerative Medicine to Drive Market Growth:

Human embryonic stem cells (ESCs) segment is expected to register significant revenue growth over the forecast period attributable to increasing use of human embryonic stem cells in regenerative medicine and tissue repair, rising application in drug discovery, and growing importance of embryonic stem cells as in vitro models for drug testing.

Cryopreservation Segment to Account for Largest Revenue Share:

Cryopreservation segment is expected to dominate other technology segments in terms of revenue share over the forecast period. Cryopreservation techniques are widely used in stem cell preservation and transport owing to its ability to provide secure, stable, and extended cell storage for isolated cell preparations. Cryopreservation also provides various benefits to cell banks and have numerous advantages such as secure storage, flexibility and timely delivery, and low cost and low product wastage.

Regenerative Medicine Segment to Lead in Terms of Revenue Growth:

Regenerative medicine segment is expected to register robust revenue CAGR over the forecast period attributable to significant progress in regenerative medicine, increasing research and development activities to expand potential of stem cell therapy in treatment of wide range of diseases such as neurodegenerative diseases, diabetes, and cancers, among others, and rapid advancement in cell-based regenerative medicine.

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North America to Dominate Other Regions in Terms of Revenue Share:

North America is expected to dominate other regional markets in terms of revenue share over the forecast period attributable to increasing adoption of stem cell therapy to treat chronic diseases, rising investment to accelerate stem cell research, approval for clinical trials and research studies, growing R&D activities to develop advanced cell-based therapeutics, and presence of major biotechnology and pharmaceutical companies in the region.

Asia Pacific Market Revenue to Expand Significantly:

Asia Pacific is expected to register fastest revenue CAGR over the forecast period attributable to increasing R&D activities to advance stem cell-based therapies owing to rapidly rising prevalence of chronic diseases such as cancer and diabetes, rising investment to accelerate development of state-of-the-art healthcare and research facilities, establishment of a network of cell banks, increasing approval for regenerative medicine clinical trials, and rising awareness about the importance of stem cell therapies in the region.

Major Companies in the Market Include:

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Market Segmentation:

For the purpose of this report, Reports and Data has segmented the stem cells market based on product, technology, therapies, application, and region:

Product Outlook (Revenue, USD Billion; 2018-2028)

Technology Outlook (Revenue, USD Billion; 2018-2028)

Therapy Outlook (Revenue, USD Billion; 2018-2028)

Application Outlook (Revenue, USD Billion; 2018-2028)

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Regional Outlook (Revenue, USD Billion, 2018-2028)

Some points on how the report benefits stakeholders:

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About Reports and Data

Reports and Data is a market research and consulting company that provides syndicated research reports, customized research reports, and consulting services. Our solutions purely focus on your purpose to locate, target, and analyze consumer behavior shifts across demographics, across industries, and help clients to make smarter business decisions. We offer market intelligence studies ensuring relevant and fact-based research across multiple industries, including Healthcare, Touch Points, Chemicals, Products, and Energy. We consistently update our research offerings to ensure our clients are aware of the latest trends existent in the market. Reports and Data has a strong base of experienced analysts from varied areas of expertise. Our industry experience and ability to develop a concrete solution to any research problems provides our clients with the ability to secure an edge over their respective competitors.

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Europe Trailed US in Record Gene and Cell Therapy Funding in 2021 – Labiotech.eu

January 17th, 2022 1:49 am

Cell and gene therapy developers globally raised an all-time annual record in 2021. However, European firms missed out on the funding growth.

Companies around the world developing cell and gene therapies raised 20.1B ($23.1B) over 2021, said the advanced therapy advocacy organization the Alliance for Regenerative Medicine (ARM) in a briefing this week. This bumper catch beat 2020s total of 17.3B ($19.9B) by 16%.

The growth from 2020 to 2021 was primarily driven by companies in the US. With a fresh 15.7B ($18B) in the bank, US-based companies saw an impressive 53% jump in investments compared to 2020. In contrast, their European counterparts raised 2.9B ($3.3B), 8% less funding than in 2020.

Both European and US gene and cell therapy players had seen record funding growth in 2020 compared to 2019, said Stephen Majors, ARMs Director of Public Affairs. However, its too early to establish why European and Asian companies havent matched the rapid cash growth seen in the US over 2021.

Its something well watch closely over the next year to determine what the causes may be and whether they are region-specific, said Majors.

Nonetheless, the funding numbers need to be interpreted in the correct context, said Antoine Papiernik, Chairman and Managing Partner of the venture capital (VC) firm Sofinnova Partners. European contributions to the field of cell and gene therapy remain immense.

Its not about how much you raise in one year; its about the level of expertise, competencies, and technologies, said Papiernik. These are the fundamentals for long-term excellence and growth, which we strongly believe in.

If there is one area where Europe is, without a doubt, on par with the US, its in new modalities, which include gene and cell therapies.

Of the various funding sources going to cell and gene therapies, VC funding increased the most in 2021, with a huge 73% jump to 8.5B ($9.8B). This trend mirrored the deluge in life sciences VC funding in the last year.

Simultaneously, gene and cell therapy companies were hit by struggling stock markets affecting the rest of the biotech sector. This mismatch is creating a bulge in funding for VC firms and potentially limiting exit options.

Inflation concerns made it particularly difficult for smaller, early-stage companies that are not yet profitable, said Majors. If inflation concerns subside in 2022, and with positive data readouts, we could see stronger performance for biotech public equities.

When the total is broken down by the types of technology getting funded, cell therapies in immuno-oncology such as CAR-T cell therapies saw the biggest funding increase: a jump of 26% since 2020. This was followed by gene therapy firms with 14% more incoming cash, and tissue engineering players, whose investments went up by 10%.

Cell therapy companies outside of immuno-oncology experienced a tighter year for financing in 2021 than in 2020, taking in 15% less funding at 1.7B ($2B). However, Majors told me that funding in this field has regularly fluctuated in the last several years.

The decrease over 2021 is not an outlier in comparison to historical trends, Majors noted. Due to the smaller size of this technology segment, just one or two financing deals can have a large impact on total financing on an annual basis.

Another important trend in the ARMs report was the rising importance of gene-editing technology. Of the total gene therapy financing, 45% was raised by companies developing gene-editing technology, up from 38% in 2018.

Investor interest in gene editing has been buoyed by clinical successes from frontrunner gene therapy players in the last year. One example from June 2021 was the promising performance of an in vivo CRISPR treatment developed by Intellia Therapeutics and Regeneron in patients with the rare disease transthyretin amyloidosis.

Gene-editing firms CRISPR Therapeutics and Vertex Pharmaceuticals are causing excitement with progress in tackling the blood disorder sickle cell disease. They are gunning to file for approval of their CRISPR gene-edited therapy for this condition in late 2022.

Investors have taken note of these early successes and see this approachs potential to treat a wide range of diseases, said Majors. Also, as this technology continues to progress, the number of companies with at least one clinical or preclinical asset in gene editing continues to rise.

Another outcome to look forward to for gene and cell therapy in 2022 is a potential record number of drug approvals. A bunch of gene therapy hopefuls including GenSight, uniQure, and BioMarin are poised to bring their candidates to the regulatory finish line in the US and Europe.

The EMA is slated to make decisions on therapies targeting aromatic l-amino acid decarboxylase deficiency, Leber hereditary optic neuropathy, and two types of hemophilia, said Majors. By the end of 2022, the number of EMA-approved gene therapies for rare diseases may have doubled from a year earlier.

However, some of the major hurdles for the field will likely be the delivery of gene and cell therapies to their target in the body as well as deciding the right dosage. The manufacture of these complex therapies is also a big bottleneck that many startups aim to tackle.

Additionally, the withdrawal of bluebird bios gene therapy from Germany in May 2021 over pricing disagreements demonstrates that regulatory approval is just the beginning for developers of gene and cell therapies. Their pricing strategy will need to walk the tightrope of making a profit while avoiding clashes with healthcare systems.

In any case, European companies will continue to play a strong role in the evolution of the cell and gene therapy sphere.

Lets not forget that the first gene therapy to be brought to the market was European, said Papiernik, referring to the gene therapy Strimvelis, which was sold by GlaxoSmithKline to Orchard Therapeutics in 2018.

Europe continues to excel in the development of gene and cell therapies and never has there been more opportunities for investment.

Cover image via Elena Resko. Inline images via the Alliance for Regenerative Medicine

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NIH researchers develop first stem cell model of albinism to study related eye conditions – National Institutes of Health

January 17th, 2022 1:49 am

News Release

Tuesday, January 11, 2022

Use of patient-derived stem cells will enable high-throughput drug screening for potential therapeutics.

Researchers at the National Eye Institute (NEI) have developed the first patient-derived stem cell model for studying eye conditions related to oculocutaneous albinism (OCA). The models development is described in the January issue of the journal Stem Cell Reports. NEI is part of the National Institutes of Health.

This disease-in-a-dish system will help us understand how the absence of pigment in albinism leads to abnormal development of the retina, optic nerve fibers, and other eye structures crucial for central vision, said Aman George, Ph.D., a staff scientist in the NEI Ophthalmic Genetics and Visual Function Branch, and the lead author of the report.

OCA is a set of genetic conditions that affects pigmentation in the eye, skin, and hair due to mutation in the genes crucial to melanin pigment production. In the eye, pigment is present in the retinal pigment epithelium (RPE), and aids vision by preventing the scattering of light. The RPE is located right next to the eyes light-sensing photoreceptors and provides them nourishment and support. People with OCA lack pigmented RPE and have an underdeveloped fovea, an area within the retina that is crucial for central vision. The optic nerve carries visual signals to the brain.

People with OCA have misrouted optic nerve fibers. Scientists think that RPE plays a role in forming these structures and want to understand how lack of pigment affects their development.

Animals used to study albinism are less than ideal because they lack foveae, said Brian P. Brooks, M.D., Ph.D., NEI clinical director and chief of the Ophthalmic Genetics and Visual Function Branch. A human stem cell model that mimics the disease is an important step forward in understanding albinism and testing potential therapies to treat it.

To make the model, researchers reprogrammed skin cells from individuals without OCA and people with the two most common types of OCA (OCA1A and OCA2) into pluripotent stem cells (iPSCs). The iPSCs were then differentiated to RPE cells. The RPE cells from OCA patients were identical to RPE cells from unaffected individuals but displayed significantly reduced pigmentation.

The researchers will use the model to study how lack of pigmentation affects RPE physiology and function. In theory, if fovea development is dependent on RPE pigmentation, and pigmentation can be somehow improved, vision defects associated with abnormal fovea development could be at least partially resolved, according to Brooks.

Treating albinism at a very young age, perhaps even prenatally, when the eyes structures are forming, would have the greatest chance of rescuing vision, said Brooks. In adults, benefits might be limited to improvements in photosensitivity, for example, but children may see more dramatic effects.

The team is now exploring how to use their model for high-throughput screening of potential OCA therapies.

NEI leads the federal governments research on the visual system and eye diseases. NEI supports basic and clinical science programs to develop sight-saving treatments and address special needs of people with vision loss. For more information, visit https://www.nei.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

Aman George, Ruchi Sharma, Tyler Pfister, Mones Abu-Asab, Nathan Hotaling, Devika Bose, Charles DeYoung, Justin Chang, David R. Adams, Tiziana Cogliati, Kapil Bharti, Brian P. Brooks. In Vitro Disease Modeling of Oculocutaneous Albinism Type I and II Using Human Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium (2022). doi: 10.1016/j.stemcr.2021.11.01.https://www.cell.com/stem-cell-reports/fulltext/S2213-6711(21)00597-X.

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Scientists uncover new information about cellular death process, previously thought to be irreversible | UIC Today – UIC Today

January 17th, 2022 1:49 am

A study published by researchers at the University of Illinois Chicago describes a new method for analyzing pyroptosis the process of cell death that is usually caused by infections and results in excess inflammation in the body and shows that process, long thought to be irreversible once initiated, can in fact be halted and controlled.

The discovery, which is reported in Nature Communications, means that scientists have a new way to study diseases that are related to malfunctioning cell death processes, like some cancers, and infections that can be complicated by out-of-control inflammation caused by the process. These infections include sepsis, for example, and acute respiratory distress syndrome, which is among the major complications of COVID-19 illness.

Pyroptosis is a series of biochemical reactions that uses gasdermin, a protein, to open large pores in the cell membrane and destabilize the cell. To understand more about this process, the UIC researchers designed an optogenetic gasdermin by genetically engineering the protein to respond to light.

The cell death process plays an important role in the body, in both healthy states and unhealthy ones, but studying pyroptosis which is a major type of cell death has been challenging, said Gary Mo, UIC assistant professor in the department of pharmacology and regenerative medicine and the department of biomedical engineering at the College of Medicine.

Mo said that methods to examine the pyroptosis mechanisms at play in live cells are difficult to control because they are initiated by unpredictable pathogens, which in turn have disparate effects in different cells and people.

Our optogeneticgasderminallowed us to skipovertheunpredictablepathogen behavior and the variable cellular responsebecause itmimics at the molecular level what happens in the celloncepyroptosisis initiated,Mo said.

The researchersappliedthis tool andusedflorescent imaging technologyto precisely activategasderminincell experimentsand observethe pores under various circumstances. They discovered that certainconditions, like specificconcentrationsof calcium ions, for example, triggered the pores to close within only tens of seconds.

This automatic response toexternalcircumstances provides evidence thatpyroptosisdynamically self-regulates.

This showed us that this form of cell death is not a one-way ticket. The process isactually programmedwith acancel button, anoff-switch, Mo said. Understanding how to control this process unlocks new avenues for drug discovery, and now we can find drugs that work for both sides it allows us to think about tuning, either boosting or limiting, this type of cell death in diseases, where we could previously only remove this important process.

Co-authors of theNature Communicationspaper,GasderminD Pores Are Dynamically Regulated by Local Phosphoinositide Circuitry,areAna Santa Cruz Garcia, KevinSchnurand Asrar Malik,all ofUIC.

The research was funded with grants from the National Institutes of Health (P01HL060678, R01HL090152, R01HL152515, T32HL007820, P01HL151327).

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Coronavirus FAQ: Why are some folks hacking home COVID tests by swabbing their throat? – Wisconsin Public Radio News

January 17th, 2022 1:49 am

Lots of folks on Twitter say that swabbing your throat in addition to your nose may be a better way of using your COVID-19 testing kit to detect the omicron variant. Is this true?

If you've used a do-it-yourself COVID-19 home test in the U.S. the "antigen" rapid tests that promise results in 15 minutes or so you know the drill. You typically swirl a cotton swab around in your nostrils, mix it with some liquid and then drop it on a test strip to await the results: positive or negative for the coronavirus.

But in recent weeks, there has been an online debate about where to stick that cotton swab. Although the directions specify a nasal swab on U.S. products, some medical professionals believe the test is more effective at detecting the coronavirus, and specifically the omicron variant, if the kit's swab is used in the throat and/or cheek in addition to the nose.

Why did this hack emerge and is there any medical science to back it up?

The idea of a throat swab is not in and of itself a radical step. Even though antigen test kits in the U.S. are designed for a nasal swab, home tests are designed for a throat swab in other countries in Canada and the U.K., for example.

The idea of improvising with a throat swab is connected to the omicron variant, which was identified in late November and has swept the world. Researchers increasingly believe omicron may replicate in the throat before the nose.

That was one of the findings of a study conducted at the University of Cape Town in South Africa. Researchers examined the ability of PCR tests to detect the variant by comparing diagnostic tests for 382 symptomatic COVID-19 patients who weren't hospitalized. In patients with the delta variant of the coronavirus, saliva swabs detected the virus 71% of the time, while nasal swabs found it 100% of the time. But in patients with omicron, researchers found the reverse: Saliva swabs detected the virus 100% of the time, while nasal swabs caught it 86% of the time.

The research has not been peer reviewed. And the tests used in the study were PCR tests, not antigen tests. (PCR tests are the gold standard and are administered typically in a health care facility; antigen tests are less precise and can be done at home. See this story for details on the differences.)

Nonetheless, the South African study has led some epidemiologists and immunologists in the U.S. to experiment with antigen tests by swabbing their throats or cheeks in addition to the nose when administering a self-test.

That's not an authorized use of the kits, reminds the Food and Drug Administration, which regulates the kits: "FACT: When it comes to at-home rapid antigen #COVID19 tests, those swabs are for your nose and not your throat," it said in a tweet issued on Jan. 7.

And even proponents of the throat swab stop short of endorsing the practice for the public without a green light from the FDA.

One of the most often quoted voices in favor of throat swabbing is Dr. Michael Mina, formerly an epidemiologist and immunologist at the Harvard T.H. Chan School of Public Health and now the chief science officer at the testing company eMed. He has tweeted: "We should be rigorously looking into throat swabs to add some level of sensitivity" and "Throat swab + nasal may improve chances a swab picks up virus."

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But Mina has gone on to tweet that the FDA was right to warn the public not to go against manufacturer's directions: "Telling US public not to go against directions is the *right* thing to do."

"The tests haven't been designed to do [throat swabs], so we don't know whether there are false positives or negatives," agrees Dr. Jill Weatherhead, assistant professor of adult and pediatric infectious diseases at Baylor College of Medicine. "It logically makes sense that you'd want to do it, but that's not how [the tests have] been developed or tested."

One potential problem could be the thicker viscosity of throat saliva, says Dr. Yuka Manabe, associate director of global health research and innovation and a professor of medicine at the Johns Hopkins Bloomberg School of Public Health. It's possible the sample would need to be filtered first, she says, to produce an accurate result.

That's not necessarily a critical concern, says Michael Daignault, an emergency physician who serves as chief medical adviser to Reliant Health Services, a medical testing company. He says that the nature of throat saliva could simply cause the test to display a message that the result is invalid rather than a false positive.

Another obvious potential problem, Manabe points out, is the length of the swab in some of the kits: "The swab that you use doesn't have a very long stick because it's just meant to be used in the front of your nose. So for you to get that into the back of your throat would not be very easy, truthfully, for some of the kits, depending on the length of the swab."

The public debate about the best way to swab has prompted a growing chorus of voices to call for new studies and a revamping of the kits and/or the instructions.

That kind of change is what Michal Tal is hoping for. Tal, an instructor at Stanford University's Institute for Stem Cell Biology and Regenerative Medicine and a visiting scientist at the Massachusetts Institute of Technology, is a proponent of throat swabs. Before seeing anyone in person, she asks that they take a coronavirus test and swab not only their nose but their cheeks, the roof of their mouth, under their tongue and if they don't gag easily their throat near the tonsils.

"I'm feeling very frustrated that the FDA and CDC didn't jump on this and try to make more rapid changes," says Tal. "The virus is always two steps ahead and we don't adapt."

At a congressional hearing Monday, the acting head of the FDA, Dr. Janet Woodcock, noted that the National Institutes of Health has helped accelerate the authorization of new home tests so that they can get the FDA's signoff in just one or two days. But she said it may take a while for companies to change their test configurations to include larger swabs for the throat.

In the meantime, she warned people not to swab their throats with the current devices, which are designed as nasal swabs. "They may stab themselves," she said. "That would not be good."

Sheila Mulrooney Eldred is a freelance health journalist in Minneapolis. She has written about COVID-19 for many publications, including The New York Times, Kaiser Health News, Medscape and The Washington Post. More at sheilaeldred.pressfolios.com. On Twitter: @milepostmedia.

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Coronavirus FAQ: Why are some folks hacking home COVID tests by swabbing their throat? - Wisconsin Public Radio News

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Founders’ Day Speaker: Breakthrough Discoveries Lead to Real World Applications – Illinois Wesleyan University

January 17th, 2022 1:49 am

Jan. 13, 2022

Health and innovative thinking was the focus of this years Founders Day Convocation at Illinois Wesleyan University.

A recording of the virtual Convocation may be viewed here.

Illinois Wesleyan President S. Georgia Nugent spoke of the motives that led to the founding of the University in 1850 and their relevance today, as well as the annual intellectual theme of Health, Healing and Humanity.

A theme that obviously could not be more relevant today, as we see these three inextricably intertwined in the context of the Coronavirus pandemic, she said.

Biomedical researcher William Murphy, a 1998 IWU Physics and math graduate, gave the keynote address titled Mimicking Nature to Create New Technology.

Murphy spoke about how his experience as a Titan helped shape his future career in biotechnology. He shared examples of his research efforts to create regenerative medicine based on materials already found in nature.

You are fortunate to be enrolled at a yes, and institution, said Murphy. You dont have to choose to become only a physicist, or only a chemist, or only a business student. You can also be a baseball player or a musician. One can engage in all of these opportunities at once to build what will become the foundation for your lifes journey.

He reminded students that every course of study can make an impact on the world.

I hope Ive convinced you today that there is so much more to discover and leverage in nature and that all disciplines can contribute to the future of biotechnology, he said. Your IWU education is preparing you wonderfully to make breakthrough discoveries and turn them into real-world products.

By Julia Perez

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Global Sports Medicine & Physiotherapy Market Research Report (2021 to 2027) – by Product, Therapy Equipment, Application, End-user and Region -…

January 17th, 2022 1:49 am

DUBLIN, Jan. 14, 2022 /PRNewswire/ -- The "Sports Medicine & Physiotherapy Market Research Report by Product, by Therapy Equipment, by Application, by End User, by Region - Global Forecast to 2027 - Cumulative Impact of COVID-19" report has been added to ResearchAndMarkets.com's offering.

The Global Sports Medicine & Physiotherapy Market size was estimated at USD 8,245.72 million in 2020, is expected to reach USD 8,944.13 million in 2021, and is projected to grow at a CAGR of 8.83% to reach USD 14,915.43 million by 2027.

Market Statistics:

The report provides market sizing and forecast across five major currencies - USD, EUR GBP, JPY, and AUD. It helps organization leaders make better decisions when currency exchange data is readily available. In this report, the years 2018 and 2019 are considered historical years, 2020 as the base year, 2021 as the estimated year, and years from 2022 to 2027 are considered the forecast period.

Competitive Strategic Window:

The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies to help the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. It describes the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth during a forecast period.

FPNV Positioning Matrix:

The FPNV Positioning Matrix evaluates and categorizes the vendors in the Sports Medicine & Physiotherapy Market based on Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that aids businesses in better decision making and understanding the competitive landscape.

Market Share Analysis:

The Market Share Analysis offers the analysis of vendors considering their contribution to the overall market. It provides the idea of its revenue generation into the overall market compared to other vendors in the space. It provides insights into how vendors are performing in terms of revenue generation and customer base compared to others. Knowing market share offers an idea of the size and competitiveness of the vendors for the base year. It reveals the market characteristics in terms of accumulation, fragmentation, dominance, and amalgamation traits.

Company Usability Profiles:

The report profoundly explores the recent significant developments by the leading vendors and innovation profiles in the Global Sports Medicine & Physiotherapy Market, including Acumed LLC, Arthrex, Inc., Bauerfeind AG, Biotek, Breg Inc, Carestream Health, Conmed Corporation, Cramer Products, DePuy Synthes, DJO Global, Inc., Include Health Inc., iTrace Biomedical Inc., KARL STORZ, KATOR LLC, MedShape, Medtronic, MTF Biologics, Mueller Sports, Inc., Performance Health International Limited, PolyPhysics, Inc., Quadrant Biosciences, RTI Surgical, RoG Sports Medicine, Smith & Nephew PLC, Stryker Corporation, Wright Medical Group N.V., Wright Medical Technology, Zimmer Biomet, and Ossur.

The report provides insights on the following pointers:1. Market Penetration: Provides comprehensive information on the market offered by the key players2. Market Development: Provides in-depth information about lucrative emerging markets and analyze penetration across mature segments of the markets3. Market Diversification: Provides detailed information about new product launches, untapped geographies, recent developments, and investments4. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, certification, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players5. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and breakthrough product developments

The report answers questions such as:1. What is the market size and forecast of the Global Sports Medicine & Physiotherapy Market?2. What are the inhibiting factors and impact of COVID-19 shaping the Global Sports Medicine & Physiotherapy Market during the forecast period?3. Which are the products/segments/applications/areas to invest in over the forecast period in the Global Sports Medicine & Physiotherapy Market?4. What is the competitive strategic window for opportunities in the Global Sports Medicine & Physiotherapy Market?5. What are the technology trends and regulatory frameworks in the Global Sports Medicine & Physiotherapy Market?6. What is the market share of the leading vendors in the Global Sports Medicine & Physiotherapy Market?7. What modes and strategic moves are considered suitable for entering the Global Sports Medicine & Physiotherapy Market?

Key Topics Covered:

1. Preface

2. Research Methodology

3. Executive Summary

4. Market Overview

5. Market Insights5.1. Market Dynamics5.1.1. Drivers5.1.1.1. Rising incidence of sports injuries worldwide5.1.1.2. Growing demand for minimally invasive surgeries5.1.1.3. Rapid introduction of new products toward treatment modalities5.1.2. Restraints5.1.2.1. Relatively high cost of implants and other devices5.1.3. Opportunities5.1.3.1. Ongoing developments in regenerative medicine5.1.3.2. Surge in adoption of computer assisted robotic surgeries to reduce recovery time5.1.4. Challenges5.1.4.1. Lack of skilled expertise in the field5.2. Cumulative Impact of COVID-19

6. Sports Medicine & Physiotherapy Market, by Product6.1. Introduction6.2. Accessories6.3. Body Reconstruction Products6.3.1. Arthroscopy Devices6.3.2. Fracture and Ligament Repair Products6.3.3. Implants6.3.4. Orthobiologics6.3.5. Prosthetic Devices6.4. Body Support and Recovery Products6.4.1. Braces and Supports6.4.2. Compression Clothing6.4.3. Physiotherapy Equipment

7. Sports Medicine & Physiotherapy Market, by Therapy Equipment7.1. Introduction7.2. Accessories7.2.1. Physiotherapy Furniture7.2.2. Physiotherapy Tapes & Bandages7.3. Equipment7.3.1. Combination Therapy Equipment7.3.2. Continuous Passive Motion Therapy Equipment7.3.3. Cryotherapy Equipment7.3.4. Electrotherapy Equipment7.3.5. Exercise Therapy Equipment7.3.6. Laser Therapy Equipment7.3.7. Magnetic & Pressure Therapy Equipment7.3.8. Shockwave Therapy Equipment7.3.9. Traction Therapy Equipment7.3.10. Ultrasound Equipment

8. Sports Medicine & Physiotherapy Market, by Application8.1. Introduction8.2. Back & Spine Injuries8.3. Cardiovascular & Pulmonary8.4. Elbow & Wrist Injuries8.5. Foot & Ankle Injuries8.6. Gynecological8.7. Hip & Groin Injuries8.8. Knee Injuries8.9. Musculoskeletal8.10. Neurological8.11. Pediatric8.12. Shoulder Injuries

9. Sports Medicine & Physiotherapy Market, by End User9.1. Introduction9.2. Ambulatory Surgery Centres9.3. Home Care Settings9.4. Hospitals9.5. Physiotherapy Centres & Clinics

10. Americas Sports Medicine & Physiotherapy Market10.1. Introduction10.2. Argentina10.3. Brazil10.4. Canada10.5. Mexico10.6. United States

11. Asia-Pacific Sports Medicine & Physiotherapy Market11.1. Introduction11.2. Australia11.3. China11.4. India11.5. Indonesia11.6. Japan11.7. Malaysia11.8. Philippines11.9. Singapore11.10. South Korea11.11. Taiwan11.12. Thailand

12. Europe, Middle East & Africa Sports Medicine & Physiotherapy Market12.1. Introduction12.2. France12.3. Germany12.4. Italy12.5. Netherlands12.6. Qatar12.7. Russia12.8. Saudi Arabia12.9. South Africa12.10. Spain12.11. United Arab Emirates12.12. United Kingdom

13. Competitive Landscape13.1. FPNV Positioning Matrix13.1.1. Quadrants13.1.2. Business Strategy13.1.3. Product Satisfaction13.2. Market Ranking Analysis13.3. Market Share Analysis, By Key Player13.4. Competitive Scenario13.4.1. Merger & Acquisition13.4.2. Agreement, Collaboration, & Partnership13.4.3. New Product Launch & Enhancement13.4.4. Investment & Funding13.4.5. Award, Recognition, & Expansion

14. Company Usability Profiles14.1. Acumed LLC14.2. Arthrex, Inc.14.3. Bauerfeind AG14.4. Biotek14.5. Breg Inc14.6. Carestream Health14.7. Conmed Corporation14.8. Cramer Products14.9. DePuy Synthes14.10. DJO Global, Inc.14.11. Include Health Inc.14.12. iTrace Biomedical Inc.14.13. KARL STORZ14.14. KATOR LLC14.15. MedShape14.16. Medtronic14.17. MTF Biologics14.18. Mueller Sports, Inc.14.19. Performance Health International Limited14.20. PolyPhysics, Inc.14.21. Quadrant Biosciences14.22. RTI Surgical14.23. RoG Sports Medicine14.24. Smith & Nephew PLC14.25. Stryker Corporation14.26. Wright Medical Group N.V.14.27. Wright Medical Technology14.28. Zimmer Biomet14.29. Ossur

15. Appendix

For more information about this report visit https://www.researchandmarkets.com/r/d6ieqy

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716

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Evolved by Nature Announces IDE Approval from the FDA to Initiate a Pivotal Clinical Trial for its first Activated Silk Dermal Filler – PRNewswire

January 17th, 2022 1:49 am

BOSTON, Jan. 12, 2022 /PRNewswire/ --Biotechnology company Evolved by Nature announced today that sister company Silk Medical Aesthetics has received Investigational Device Exemption (IDE) approval from the FDA to initiate a pivotal clinical trial for its new dermal filler for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.

The new filler leverages Evolved by Nature's all-natural Activated Silk protein technology platform, infusing it within a crosslinked hyaluronic acid gel with lidocaine. It isdesigned to be biodegradable and reversible for use in soft tissue augmentation such as for wrinkle filling and volumizing. The filler is the first in a differentiated product line being developed to provide both the patient and physician with new options in aesthetic medicine to address needs from facial skin smoothing and contouring to enhancing skin attributes for improved patient outcomes.

The randomized, controlled, blinded, prospective pivotal clinical trial will establish the Activated Silk dermal filler's safety and efficacy versus a commercially FDA-approved available control. Silk Medical Aesthetics will initiate the study with multiple centers in Q1 2022, and trial results will be submitted in a future Premarket Approval (PMA) application to the FDA to support regulatory approval.

Primary endpoint data for the feasibility clinical trial on the Activated Silk filler, announced in late 2021, demonstrated a favorable safety profile with high patient satisfaction and clinically meaningful improvement in NLF severity. Zero device-related adverse events were reported, and 83.7% of patients had a clinically meaningful improvement in wrinkle severity at the 13-week primary timepoint. 100% of clinicians and patients reported improvement on the Global Aesthetic Improvement Scale (GAIS).

Evolved by Nature CEO, Dr. Greg Altman, commented, "We've always known that Activated Silk protein technology has the potential to dramatically restore or improvebarrier function, on everything from skin to textiles used by the fashion industry, and more. This IDE approval is a tremendous benchmark as we rapidly expand our development pipeline, exploring and developing medical devices, therapeutics, and bioactive molecules for regenerative medicine."

About Evolved by Nature: Founded in 2013 in Boston, MA, Evolved by Nature is a biotechnology company that creates renewably sourced solutions to human health needs. Activated Silk biotechnology leverages natural silk protein to create sustainable molecules that protect, repair, and enhance the barrier function of anything with a surface. Enabling the next generation of products that advance the health of people and the planet, Evolved by Nature has unlocked breakthrough applications for Activated Silk biotechnology within textiles, personal care, aesthetic and medical treatments, therapeutics and more, with limitless possibilities. http://www.evolvedbynature.com

About Silk Medical Aesthetics: Silk Medical Aesthetics is a Boston-based company on a mission to create the next-generation dermal filler platform by leveraging the power of natural silk. A sister company of biotechnology company Evolved by Nature, Silk Medical Aesthetics was founded by silk experts Drs. Greg Altman and Rebecca Lacouture in 2018, received more than $18 million in Series A and B financing, and is backed by a diverse group of investors. http://www.silkmedicalaesthetics.com

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Evolved by Nature Announces IDE Approval from the FDA to Initiate a Pivotal Clinical Trial for its first Activated Silk Dermal Filler - PRNewswire

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